search
Back to results

Clinical Assessment of Next Science Wound Gels in Healing Below the Knee Amputation Surgical Wound Compared to SOC

Primary Purpose

Surgical Wound, Surgical Site Infection, Surgical Wound Infection

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Next Science Wounds Gels
Sponsored by
Next Science TM
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Wound focused on measuring BKA, biofilm, Next Science

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or non-pregnant female 18 years or older
  2. Participant must be undergoing below the knee amputation with primary closure or completion below the knee amputation with primary closure.
  3. There must be no infection present at the surgical incision site
  4. Participant is determined to NOT require endovascular or vascular reconstructive surgery to restore blood flow to the wound within the study period
  5. Must have a popliteal pressure on arterial doppler of 40 mm Hg or higher in the surgical leg or angiographic evidence of popliteal artery flow
  6. No known allergic reaction or sensitivity to investigational product or components
  7. Willing and able to comply with all study procedures including transportation to the study site for all scheduled visits and be available for the duration of the study
  8. Provide signed and dated informed consent

Exclusion Criteria:

  1. Male or Female less than 18 years old
  2. Pregnancy as determined by pre-op urine hCG testing on the day of surgery for women of childbearing potential (women are considered clinically post-menopausal if over 12 consecutive months without a menstrual period)
  3. Systemic sepsis at the time of surgery
  4. Disseminated Cancer Patients
  5. Current long-term (more than 30 consecutive days) use of moderate or high dose oral corticosteroids
  6. Current long-term (more than 30 consecutive days) use of immune modulators/suppressors
  7. Known sensitivity to investigational product or any components
  8. Participants with HIV or acquired immunodeficiency syndrome (AIDS) or any other immunodeficient states
  9. Any disease or prior/planned surgery or other situation that in the investigator's opinion may interfere with the participant successfully completing the study.
  10. Overlapping participation in another treatment or interventional clinical trial.
  11. Family members or students of the Investigator or clinical site.
  12. Safety exclusion criterion: At the end of the procedure, the surgeon and PI can discuss to withdraw the patient, if it is felt that continuing in the study will be detrimental to the patient. For example, if the incision cannot be closed, or if it requires a muscle flap, or if the incision site encounters contamination or infection not recognized prior to the start of surgery. The decision to withdraw the patient will be made in the OR, prior to being randomized.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Next Science

    Control

    Arm Description

    Following amputation, SurgX™ will be applied directly to the surgical incision in the operating room under sterile conditions and covered with SOC dressing. The surgical dressing will not be removed until post-operative day 3, except if deemed necessary by the treating surgeon. At that time, direct application of the BlastX™ to the incision will be placed, then covered with a SOC dressing. BlastX™ will be applied every day and covered with SOC dressing.

    Post-op SOC dressing as per treating research doctor to include dressing changes post-op day 3 and daily thereafter.

    Outcomes

    Primary Outcome Measures

    Percentage of Incisional Wound Area Change
    Incisional wounds treated with SurgX™, BlastX™ and SOC Treatment will have higher percentage of area reduction than SOC alone after 28 days of treatment.
    Time to when Patient is Ready for Prosthetic Fitting
    Participants treated with SurgX™, BlastX™ and SOC treatment will be deemed ready to be fitted with a prosthetic limb earlier (days) than those in the SOC Control Group.

    Secondary Outcome Measures

    Bioburden
    The amount of viable microorganisms persisting in wounds (CFU) treated with SurgX™, BlastX™ and SOC treatment will be less than those in the SOC Control Group at one or more of the measured time points.
    Bioburden
    The semi-quantitative amount of DNA measured microorganisms persisting in wounds treated with SurgX™, BlastX™ and SOC will be less when compared to the SOC Control Group at one or more of the measured time points.
    Bioburden
    The number of DNA measured microorganisms persisting in wounds treated with SurgX™, BlastX™ and SOC treatment will be less when compared to the SOC Control Group at one or more of the measured time points.
    Wound Area Reduction
    Percentage of surgical wound area change after treatment with SurgX™ at the time of the procedure plus 14 and 21 days of treatment with BlastX™ wound gel compared to SOC.

    Full Information

    First Posted
    August 9, 2019
    Last Updated
    April 17, 2023
    Sponsor
    Next Science TM
    Collaborators
    University of Maryland, Baltimore
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04053946
    Brief Title
    Clinical Assessment of Next Science Wound Gels in Healing Below the Knee Amputation Surgical Wound Compared to SOC
    Official Title
    Clinical Assessment of the Next Science BlastXTM Antimicrobial Gel and SurgXTM Antimicrobial Gel Healing Efficacy for Below the Knee Amputation Surgical Wound Compared to Standard of Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Site backed out
    Study Start Date
    October 1, 2019 (Anticipated)
    Primary Completion Date
    October 1, 2021 (Anticipated)
    Study Completion Date
    October 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Next Science TM
    Collaborators
    University of Maryland, Baltimore

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a 64-patient, 90-day, open -label study on adult patients undergoing below knee amputation for various etiologies. The objective of this study is to assess surgical wound healing and wound bioburden using combination treatment of Next Science SurgX™ Antimicrobial Wound Gel and BlastX™ Antimicrobial Wound Gels as compared to standard of care.
    Detailed Description
    This is a prospective, randomized, 90 day, open-label study of patients undergoing below the knee amputation (BKA) with primary closure or completion. Patients who present for BKA with primary closure or completion will have had a pre-op medical evaluation prior to being screened against the protocol's inclusion/exclusion criteria. If criteria are met, patients will be presented with the option to participate in the study and informed consent procedures will be carried out, in compliance with currently applicable participants' rights and safety regulations. A minimum of 64 participants, with up to 70 participants, may be enrolled. A participant requiring bilateral BKA will be excluded. Eligible subjects will need to complete the study to meet the primary endpoint. It is estimated that the study enrollment period will last approximately eighteen months, and the duration of each participants' participation will be three months. Visits in the treatment portion of the study will be carried out at day 0, 3, 14, 21, and 28 days with a scheduling window of 3 days before or after each due date. A phone call follow-up will be conducted at 60 days post-surgery with a window of 7 days before or 14 days after to inquire about the incision (appearance of incision or any noted changes since prior study visit), and overall health of the participant. All participants, regardless of treatment arm, will complete Visit 6 (90 day follow up) with a scheduling window of 7 days before or 21 days after. The key parameters of the study include: percentage of surgical wound area reduction, time patients are deemed ready prosthetic healing, and microorganism type and amounts. Bacterial identification and quantification will occur at days 0, 14, and 28 for all participants.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Surgical Wound, Surgical Site Infection, Surgical Wound Infection, Amputation Stump; Infection, Surgical Incision
    Keywords
    BKA, biofilm, Next Science

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Next Science
    Arm Type
    Experimental
    Arm Description
    Following amputation, SurgX™ will be applied directly to the surgical incision in the operating room under sterile conditions and covered with SOC dressing. The surgical dressing will not be removed until post-operative day 3, except if deemed necessary by the treating surgeon. At that time, direct application of the BlastX™ to the incision will be placed, then covered with a SOC dressing. BlastX™ will be applied every day and covered with SOC dressing.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Post-op SOC dressing as per treating research doctor to include dressing changes post-op day 3 and daily thereafter.
    Intervention Type
    Device
    Intervention Name(s)
    Next Science Wounds Gels
    Intervention Description
    SurgX will be applied once at closure while BlastX will be applied everyday until day 28 with each dressing change.
    Primary Outcome Measure Information:
    Title
    Percentage of Incisional Wound Area Change
    Description
    Incisional wounds treated with SurgX™, BlastX™ and SOC Treatment will have higher percentage of area reduction than SOC alone after 28 days of treatment.
    Time Frame
    28 Days
    Title
    Time to when Patient is Ready for Prosthetic Fitting
    Description
    Participants treated with SurgX™, BlastX™ and SOC treatment will be deemed ready to be fitted with a prosthetic limb earlier (days) than those in the SOC Control Group.
    Time Frame
    Day 0 to 90 Days
    Secondary Outcome Measure Information:
    Title
    Bioburden
    Description
    The amount of viable microorganisms persisting in wounds (CFU) treated with SurgX™, BlastX™ and SOC treatment will be less than those in the SOC Control Group at one or more of the measured time points.
    Time Frame
    Day 0, Day 14, Day 28
    Title
    Bioburden
    Description
    The semi-quantitative amount of DNA measured microorganisms persisting in wounds treated with SurgX™, BlastX™ and SOC will be less when compared to the SOC Control Group at one or more of the measured time points.
    Time Frame
    Day 0, Day 14, Day 28
    Title
    Bioburden
    Description
    The number of DNA measured microorganisms persisting in wounds treated with SurgX™, BlastX™ and SOC treatment will be less when compared to the SOC Control Group at one or more of the measured time points.
    Time Frame
    Day 0, Day 14, Day 28
    Title
    Wound Area Reduction
    Description
    Percentage of surgical wound area change after treatment with SurgX™ at the time of the procedure plus 14 and 21 days of treatment with BlastX™ wound gel compared to SOC.
    Time Frame
    Baseline to 21 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or non-pregnant female 18 years or older Participant must be undergoing below the knee amputation with primary closure or completion below the knee amputation with primary closure. There must be no infection present at the surgical incision site Participant is determined to NOT require endovascular or vascular reconstructive surgery to restore blood flow to the wound within the study period Must have a popliteal pressure on arterial doppler of 40 mm Hg or higher in the surgical leg or angiographic evidence of popliteal artery flow No known allergic reaction or sensitivity to investigational product or components Willing and able to comply with all study procedures including transportation to the study site for all scheduled visits and be available for the duration of the study Provide signed and dated informed consent Exclusion Criteria: Male or Female less than 18 years old Pregnancy as determined by pre-op urine hCG testing on the day of surgery for women of childbearing potential (women are considered clinically post-menopausal if over 12 consecutive months without a menstrual period) Systemic sepsis at the time of surgery Disseminated Cancer Patients Current long-term (more than 30 consecutive days) use of moderate or high dose oral corticosteroids Current long-term (more than 30 consecutive days) use of immune modulators/suppressors Known sensitivity to investigational product or any components Participants with HIV or acquired immunodeficiency syndrome (AIDS) or any other immunodeficient states Any disease or prior/planned surgery or other situation that in the investigator's opinion may interfere with the participant successfully completing the study. Overlapping participation in another treatment or interventional clinical trial. Family members or students of the Investigator or clinical site. Safety exclusion criterion: At the end of the procedure, the surgeon and PI can discuss to withdraw the patient, if it is felt that continuing in the study will be detrimental to the patient. For example, if the incision cannot be closed, or if it requires a muscle flap, or if the incision site encounters contamination or infection not recognized prior to the start of surgery. The decision to withdraw the patient will be made in the OR, prior to being randomized.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Khanjan H Nagarsheth, MD, MBA, FACS, RPVI
    Organizational Affiliation
    University of Maryland
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Clinical Assessment of Next Science Wound Gels in Healing Below the Knee Amputation Surgical Wound Compared to SOC

    We'll reach out to this number within 24 hrs